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Clinical Practice Guidelines for the management of locally advanced ...

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For non-metastatic disease <strong>the</strong>re were two studies 11, 57, 58 , one (supported by industry) compared<br />

bicalutamide with castration, and <strong>the</strong> o<strong>the</strong>r 21 (not supported by industry) compared two LHRH<br />

agonists with cyproterone acetate and clinical monitoring. Both studies showed that castration was<br />

associated with poorer sexual function than anti-androgen mono<strong>the</strong>rapy. In <strong>the</strong> bicalutamide study,<br />

physical capacity as measured with <strong>the</strong> Cleary instrument was improved with bicalutamide, however,<br />

<strong>the</strong>re were no significant differences in <strong>the</strong> o<strong>the</strong>r eight domains.<br />

Only one study 21, 59 had patients randomised to a non-treatment arm in a clinical environment in which<br />

commencement <strong>of</strong> androgen deprivation was triggered increasingly by a raised PSA <strong>for</strong> patients not<br />

having treatment with curative intent. The numbers in this study are small but <strong>the</strong>y reported a<br />

significant increase in emotional distress <strong>for</strong> <strong>the</strong> non-treatment arm (p = 0.002) with increased sexual<br />

dysfunction at one year <strong>for</strong> all three treatment arms, particularly <strong>for</strong> goserelin (p < 0.001).<br />

In <strong>the</strong> adjuvant setting, long-term quality-<strong>of</strong>-life impacts related to <strong>the</strong>rapy, when dealing with <strong>the</strong><br />

‘chance <strong>of</strong> having cancer’, present ano<strong>the</strong>r paradigm. These studies reported radio<strong>the</strong>rapy adverse<br />

events ra<strong>the</strong>r than quality <strong>of</strong> life outcomes using validated instruments.<br />

Evidence summary Level References<br />

Using validated quality <strong>of</strong> life assessment questionnaires:<br />

For non-metastatic prostate cancer <strong>the</strong>re was evidence that<br />

medical or surgical castration is associated with poorer sexual<br />

function when compared with non-steroidal anti-androgen<br />

mono<strong>the</strong>rapy.<br />

II 11, 57,<br />

58,21, 59<br />

Since all quality-<strong>of</strong>-life studies examined report overall group findings, <strong>the</strong>y should be regarded in a<br />

general sense when supporting individual patients in <strong>the</strong>ir treatment choices. This relates in particular<br />

to timing <strong>the</strong> commencement <strong>of</strong> androgen deprivation because <strong>of</strong> <strong>the</strong> absence <strong>of</strong> a clear and<br />

significant overall survival benefit with early versus later introduction <strong>of</strong> ADT.<br />

Recommendation<br />

Toxicities should be considered in <strong>the</strong> context <strong>of</strong> what is important to each individual patient,<br />

as <strong>for</strong> some patients impairment <strong>of</strong> sexual function may have a significant impact on <strong>the</strong>ir<br />

quality <strong>of</strong> life and overall adjustment, as well as affecting adversely those close to <strong>the</strong>m.<br />

Grade C<br />

Intermittent or continuous ADT<br />

See section 5.1.6<br />

3.1.2 Radio<strong>the</strong>rapy<br />

Definitive external beam radio<strong>the</strong>rapy techniques <strong>for</strong> <strong>locally</strong> <strong>advanced</strong> disease<br />

There are nine randomised controlled trials comparing various definitive external beam radio<strong>the</strong>rapy<br />

techniques that include men with <strong>locally</strong> <strong>advanced</strong> disease. These studies investigate:<br />

limited versus extended field radio<strong>the</strong>rapy (three trials)<br />

various dose regimens (four trials), and<br />

con<strong>for</strong>mal versus conventional techniques (two trials).<br />

25<br />

Locally <strong>advanced</strong> disease

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